Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

NCT03452722 | Completed DMC

• 1 other identifier: 13.06.1.1.12
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.

Conditions

Hypertensive Intracerebral Hemorrhage; Intraventricular Hemorrhage; Brain Injuries

Keywords

secondary brain injury; neuroinflammation

Outcome Measures

Primary Outcomes (1)

• Cytokine concentration difference between two groups

  Cytokine concentration measured from CSL

  Samples taken on day 0, day 1, day 3 and day 7.

Study Arms (2)

Study group

Applied rtPA

Drug: intraventricual recombinant tissue plasminogen activator application

Control study

rtPA not applied

Interventions

intraventricual recombinant tissue plasminogen activator application DRUG

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All subjects from 18 to 80 years.

You may qualify if:

• Subjects with primary ICH with IVH
• ICH score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle
• Patient is not considered a surgical candidate by neurosurgery service

You may not qualify if:

• No history of diseases or drugs that affect the immunological system.
• ICH score 1 and 5
• Current participation in another research drug treatment protocol
• Previously known intracranial arteriovenous malformation or aneurysms
• Intracerebral hematoma considered to be related to trauma
• ICH is located in the pons
• Blood in the subarachnoid space visualized on CT scan

Sponsors & Collaborators

• University of Rijeka: lead

Related Publications (2)

• Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.

  PMID: 28081952 BACKGROUND

• Dunatov S, Antoncic I, Bralic M, Jurjevic A. Intraventricular thrombolysis with rt-PA in patients with intraventricular hemorrhage. Acta Neurol Scand. 2011 Nov;124(5):343-8. doi: 10.1111/j.1600-0404.2010.01481.x. Epub 2011 Feb 8.

  PMID: 21303348 BACKGROUND

MeSH Terms

Conditions

Intracranial Hemorrhage, Hypertensive; Brain Injuries; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vlatka Sotosek Tokmadzic, PhD

  University of Rijeka

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 2, 2018
• Study Start: June 1, 2011
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2018
• Last Updated: March 26, 2019

Record last verified: 2019-03